FDA Updates Articles
FDA approved Esperoct (antihemophilic factor[recombinant], glycopegylatedexei), an extended half-life factor VIII molecule for replacement therapy in people with hemophilia A.
FDA issuing documents that should lead to smaller clinical trials, faster approvals and quicker launches of nonopioid pain medications.
FDA has approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive
therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura.
FDA has approved Grifols’ GamaSTAN to treat people exposed to measles and the hepatitis A viruses.
FDA has approved Amgen’s romiplostim to treat pediatric patients ages 1 year and older with immune thrombocytopenia for a minimum of six months and who have had an insufficient response to corticosteroids, immune globulin or splenectomy.
FDA has approved Xospata (gilteritinib) to treat adult patients with relapsed or refractory acute myeloid leukemia with a certain genetic mutation.
FDA granted Sanofi Pasteur’s Adacel Tdap absorbed vaccine expanded indication to include repeat vaccinations for tetanus, diphtheria and pertussis.
The U.S. Food and Drug Administration (FDA) has approved Bayer’s Jivi (BAY94-9027) as a preventive treatment for bleeding in hemophilia A.
Genentech’s baloxavir marboxil, an experimental, single-dose flu drug, has been given priority review by the U.S. Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) has approved Shire’s Cinryze (C1 esterase inhibitor [human]) to prevent angioedema attacks in children 6 years and older with hereditary angioedema.
The U.S. Food and Drug Administration (FDA) has approved Incyte Corp.’s Olumiant (baricitinib) 2 mg once-daily oral medication to treat adults with moderately to severe active rheumatoid arthritis.
The U.S. Food and Drug Administration has approved the first prescription drug made from marijuana.